Senior Project Manager, Global Medical Affairs, Immunology

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Job Summary:

Leads Operational Management for the Global Medical Affairs Program (Immunology) and is a champion for cross-functional and cross-regional collaboration with seamless, efficient delivery of Global Medical Affairs (GMA) objectives on time and on budget. Develops, with Global/Regional Medical Leadership, Global Medical Affairs and Franchise Program Actions Plans from MSD, providing monthly updates and mitigations plans as needed. Develops Project Plans for Other Key Global Medical Program Activities, Projects, Programs, based on Medical Strategy, tracking status in monthly reports. Leads project management and tactical operational support for certain Global Medical Activities or Projects. The role owns oversight of Global Tactical Execution and Budget spend; tracking and transparently reporting status, changes and/or mitigation to Global Medical Leadership. The role supports internal review processes for Immunology Global Medical Projects and facilitates team execution. Role communicates regularly with global and regional finance and operations on budget and status; and manages Shepards financial processes for GMA tactics. 

Essential Functions:

Leads Operational Management for the Global Medical Affairs Product Strategic Plan

• Champion key internal processes for medical review of certain global activities, projects, or programs; and manages those processes smoothly for GMA.
• Applies program management expertise, methodologies, and standards to support the GMA Team
• Develops and executes continuous improvements; tracks objectives and key results and metrics; and implements best practices in support of process improvements.
• Facilitates and coordinates group/team meetings, ensuring results-oriented meetings and positive team dynamics. Defines and delegates responsibilities, goals, and deliverables with team members in support of GMA Team.
• Provides regular reports and communicates effectively with team members, senior leaders, and key stakeholders on assigned program's progress, issues, risks, needs, and opportunities
• Develops, maintains, tracks, and manages high quality, integrated project plan, including clearly identified critical paths and key risks as appropriate
• Partner closely with the Finance department with developing, maintaining, tracking, and managing the budget and by identifying budgetary impacts of strategic and critical issues

Champion of Key Global Medical Affairs Processes & Meetings

• Track and communicate all key timelines for deliverables (e.g. Medical Affairs plan, monthly and quarterly reports, annual budget planning process)
• Collaborate with team on the creation of contracts, purchase orders, consulting agreements, and meeting contents for medical meetings (e.g. Ad Boards) and specified projects.
• Support tracking, analysis, and reconciliation of invoices and purchase orders regarding meetings and specified projects.
• Maintain and manage Medial Affairs databases for respective TA (e.g. SharePoint / Teams)
• Develops global monthly insight reports, integrated from regional reports and in alignment with new GMA Processes.
• Collaborate with team to develop and champion appropriate governance, charters, and global meeting cadence
• Organize, coordinate, and execute Global Meetings (logistics, financial administration, medical reviews as required and documentation)
• Project manage relevant Medical Affairs team meetings and work streams, quarterly review meetings, and governance associated follow-up on actions and reporting.
• Maintain Project tracking and documentation e.g. functional activity status, critical activities, remediation plans, status updates for the Global Leadership

Job Requirements:

Education

Bachelor’s degree with scientific focus.  Advance scientific or business degree preferred.  Project Management qualification (PMP or equivalent) required.

Experience

• Minimum five (5) years project management experience within the biotech/pharmaceutical industry working with cross-functional project teams in a global